Summary: Recall and Discontinuation of Q’Apel Medical’s 072 Aspiration System
Summary: Recall and Discontinuation of Q’Apel Medical’s 072 Aspiration System
1. Device Affected: Q’Apel Medical’s 072 Aspiration System, which includes the Hippo aspiration catheter and Cheetah guiding system, used for stroke thrombectomy in cases of large vessel occlusion (LVO).
2. Reason for Recall: The U.S. FDA issued a warning letter citing concerns about the distal tip design of the Hippo catheter.
3. Recall Classification: The FDA classified the action as a Class I recall, indicating that use of the device may cause serious injury or death.
4. Company Action: Q’Apel Medical has voluntarily recalled and discontinued the device, stating it will focus on developing next-generation technologies.
5. Adverse Events: Three adverse events were reported:
• One tip detachment (resolved without harm)
• One vessel rupture
• One vasospasm
6. Geographic Distribution: The device was distributed in the U.S., Qatar, UAE, and Kazakhstan.
7. Recall Scope: A total of 1,617 device lots are included in the recall.
8. Next Steps for Users: Consignees are advised to return all unused inventory immediately and notify any third-party recipients.
9. Company Statement: Q’Apel believes other factors may have contributed to the events and is continuing to monitor the situation closely.
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Source: U.S. Food and Drug Administration (FDA)
Full Advisory Link: FDA Recall Notice – Q’Apel 072 Aspiration System
